Breathe Easier, Join the Competition

Often, the best strategy in drug development isn't to beat the current offerings, but to show a drug can be used as an add-on therapy to improve the standard of care. Cancer and HIV drugs have been doing it for years, and Novartis (NYSE: NVS) is getting in on the act with Onbrez Breezhaler, which treats chronic obstructive pulmonary disease, or COPD.

In two phase 3 trials, Onbrez combined with Spiriva HandiHaler, marketed by Boehringer Ingelheim and Pfizer (NYSE: PFE) , improved lung function better than Spiriva alone. Rather than competing with Spiriva, Novartis would be able to use Spiriva's patient base to its advantage, especially among patients that Spiriva isn't helping fully.

The findings aren't all that surprising. Both drugs have been shown to work independently and they have different mechanisms of action to improve lung function; combining them was the obvious next step.

Novartis released a lot of data beyond the top-line results, but it's still a little hard to know how the combination compares to other COPD drugs such as GlaxoSmithKline's (NYSE: GSK) Advair, Merck's (NYSE: MRK) Foradil, and AstraZeneca's (NYSE: AZN) Symbicort. Even with the full data, which will be presented at a medical meeting in May, we won't have a really good idea until the companies run a head-to-head trial comparing the Onbrez-Spiriva combination with another drug.

Onbrez is already approved for marketing in 50 countries including the European Union. In the U.S., it'll go by the name Arcapta Neohaler and is expected to go in front of an FDA advisory committee next month. The new data will likely have to be added as a supplemental application after the drug is approved as a monotherapy, but doctors would be able to prescribe the drug in combination with Spiriva as soon as it's launched stateside.

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